NCT04471922

A Multiple Ascending High Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects

A Single-center, Randomized, Double-blinded, Placebo and Active Controlled Phase 1 Study to Evaluate the Safety and Pharmacology of Multiple Ascending Dose Administration of Anaprazole in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A single-center, randomized, double-blinded, placebo parallel controlled phase 1 study to evaluate the safety and pharmacokinetics/pharmacodynamics of multiple (7 days) ascending dose (60mg QD, 80mg QD, 100mg Qd) administrationof Anaprazole in healthy Chinese subjects. 45 subjects, 15 subjects for each dose group. In each dose group, 10 subjects take investigational drug (anaprazole), 2 subjects take active comparatory drug (rabeprazole), 3 subjects take placebo.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Anaprazole Sodium enteric-coated tablet	Multiple ascendinng dose, anaprazole 60mg QD(60mg QD group), 80mg QD(80mg QD group), 100mg QD(100mg QD group) , 7 days, fasting oral administration.
DRUG	Placebo	Multiple dose, 1 tablet QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration.
DRUG	Active controlled (rabeprazole)	Multiple dose, rabeprazole 20mg QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration.

Timeline

• Start date: 2019-03-21
• Primary completion: 2019-03-28
• Completion: 2019-03-28
• First posted: 2020-07-15
• Last updated: 2020-07-15

Locations

1 site across 1 country: China